Impact of Exercise Training on Frailty in CVD Patients.

NCT04675437 | Unknown

• 1 other identifier: FR-AT-CVD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research project is to examine the impact of aerobic exercise on markers of frailty in patients (of 65 years or older) suffering from heart failure (HF) or after coronary artery bypass grafting (CABG) or mini aortic valve replacement procedures (mini-AVR).

Conditions

Frailty; Cardiovascular Diseases

Keywords

frailty; older adults; cardiovascular diseases; cardiac rehabilitation

Outcome Measures

Primary Outcomes (9)

• Change in body weight

  To examine whether there was a change in body weight (not due to a diet) in the last year

  At baseline (as part of the identification of frailty)

• Gait speed

  To examine the gait speed based on the 4.6 metres walking test.

  At baseline (as part of the identification of frailty)

• Change in gait speed at 12 weeks

  To examine the change in gait speed based on the 4.6 metres walking test.

  12 weeks

• Level of physical activity based on the Katz-scale

  To examine the level of physical activity based on the Katz-scale (which measures the level of (in)dependence in activities of daily living) (score of 0-6 in which a higher score indicates a better level of physical activity)

  At baseline (as part of the identification of frailty)

• Change in level of physical activity at 12 weeks (0-6) (Higher score = better level of physical activity)

  To examine the change in level of physical activity based on the Katz-scale (which measures the level of (in)dependence in activities of daily living) (score of 0-6 in which a higher score indicates a better level of physical activity)

  12 weeks

• Exhaustion based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)

  To examine whether the patients suffer from exhaustion based on two questions of the CES-D (in which a score of 2 or 3 on both questions indicates that the patient suffers from exhaustion)

  At baseline (as part of the identification of frailty)

• Change in level of exhaustion at 12 weeks based on 2 questions of the Center of Epidemiologic Studies Depression Scale (CES-D)

  To examine whether there is a change in the level of experienced exhaustion based on two questions of the CES-D (in which a score of 2 or 3 on both questions indicates that the patient suffers from exhaustion)

  12 weeks

• Handgrip strength

  To examine the handgrip strength measured with the Jamar handheld dynamometer.

  At baseline (as part of the identification of frailty)

• Change in handgrip strength at 12 weeks

  To examine the change in handgrip strength measured with the Jamar handheld dynamometer.

  12 weeks

Secondary Outcomes (10)

• Nutritional status based on the Mini Nutritional Assessement (MNA)

  At baseline (as part of the identification of frailty)

• Change in nutritional status at 12 weeks based on the Mini Nutritional Assessement (MNA)

  12 weeks

• Cognitive status based on the Mini Mental State Examination (MMSE)

  At baseline (as part of the identification of frailty)

• Change in cognitive status at 12 weeks based on the Mini Mental State Examination (MMSE)

  12 weeks

• Physical status/Comorbidities based on the intake of medications

  At baseline (as part of the identification of frailty)

Study Arms (1)

Frail patients (CABG, HF or mini-AVR)

EXPERIMENTAL

12-weeks cardiac exercise program (3 sessions per week) consisting of aerobic exercises (ergometer, treadmill and arm ergometer).

Other: Aerobic exercise

Interventions

Aerobic exercise OTHER

12-weeks aerobic exercise program

Frail patients (CABG, HF or mini-AVR)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women of at least 65 years of age at the start of the study
• To be admitted to Jessa Hospital Hasselt for cardiac rehabilitation after CABG or mini-AVR surgery or because of HF
• Diagnosed as being frail based on the Phenotype of Fried.

You may not qualify if:

• A persistently unstable clinical condition (e.g. angina, advanced conduction disturbances, threatening ventricular arrhythmias or acute HF)

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Frailty; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dominique Hansen, Prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nastasia Marinus, Msc

CONTACT

003211269203; nastasia.marinus@uhasselt.be

Dominique Hansen, Prof. dr.

CONTACT

003211292126; dominique.hansen@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 19, 2020
• Study Start: October 20, 2020
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)